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The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent breast cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on predetermined evaluation criteria | Each 49 day course of treatment until withdrawal or unacceptable toxicity | |
| Safety: incidence and severity of adverse events, laboratory test abnormalities | Each 49 day course of treatment until withdrawal or unacceptable toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response, defined as either Complete or Partial Response, based on Evaluation Criteria on Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer | Each 49 day course of treatment until withdrawal or unacceptable toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| C089957 | BMS 181339 |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |